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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hydrazone Colorimetry, Alt/Sgpt
510(k) Number K941192
Device Name ORTHO ALT MICROWELL TEST SYSTEM
Applicant
Ortho Diagnostic Systems, Inc.
1001 U.S. Hwy. 202
P.O Box 350
Raritan,  NJ  08869
Applicant Contact KIM W GRAY
Correspondent
Ortho Diagnostic Systems, Inc.
1001 U.S. Hwy. 202
P.O Box 350
Raritan,  NJ  08869
Correspondent Contact KIM W GRAY
Regulation Number862.1030
Classification Product Code
CKD  
Date Received03/14/1994
Decision Date 05/16/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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